Kornimate/medical-research-clean huggingface dataset:
bioglue or vivostat in the control of air leak in thoracic surgery

Conditions: Thoracic Surgery; Air Leak

Summary: following lung surgery air may continue to leak from the surface of the lung. chest drains are placed to allow this air to be removed safely and prevent the lung from collapsing. drains need to remain until the air leak from the lung has ceased. air which continues to leak results in longer chest drainage times which cause increased discomfort and immobility for patients. these patients are at risk of secondary complications such as infection. longer hospital stays and increased costs ensue. a randomised controlled trial (rct) conducted at the royal brompton hospital has shown clear benefits in the management of difficult air leak with the use of bioglue. bioglue is a surgical sealant applied to the surface of the lung at the time of surgery. bioglue is of bovine origin. concerns exist regarding the potential risk of transmission of blood borne diseases with bovine derived medical products. should a surgical adhesive without these potential risks prove as effective as bioglue then its use could be commended. the vivostat system is a medical system that derives a sealant from the patient's own blood. a small study has shown that it may also be of benefit in the management of difficult air leaks. the principal aim of our rct is to compare the duration of air leak, length of chest drainage and hospital stay associated with bioglue to that of vivostat.


Eligibility criteria:
inclusion criteria: * adults (18 years and over) * males and females * patients undergoing any thoracic surgical procedure likely to result in alveolar air leak. * written informed consent exclusion criteria: * age less than 18 years * pregnancy * breast feeding * previous treatment with bioglue or vivostat * inability to give informed consent * pneumonectomy * empyema * grade 0 air leak

Keywords: air leak thoracic surgery sealants
an interactive web-based intervention to achieve healthy weight in young children

Conditions: Child; Obesity; Overweight

Summary: the overall purpose of this study is to develop and implement an effective intervention program designed to prevent and treat obesity in young children.

study procedures and interventions: pre-intervention: a full-day training will occur with a physician and nurse from each clinic site to be trained as "champions" in counseling. intervention: a letter of introduction will be mailed to potential subjects whose child was seen in the last 6 months for a well-child exam whose bmi is greater than or equal to the 85th percentile. after informed consent is obtained, the subjects will be randomized to the intervention or control group. one parent may join the study. groups of 10 to 12 parents of overweight and obese 3 to 6 year olds will meet once weekly for 6 weeks at 5:30 to 6:30 pm with the "nurse champion" in the primary care office. topics to be presented and discussed include authoritative parenting, using the food plan "go, slow, and whoa", increasing physical activity, and behavior change strategies. sessions will be audiotaped and independently audited to confirm program fidelity. parenting skills will be discussed at every session. the intervention group will have access to a website. this site will include information services (instant library with health topics related to nutrition and physical activity and answers to frequently asked questions), web links to other pre-screened sources of information on nutrition and physical activity, local resources for current activities for children and families, personal stories (emphasizing authoritative parenting), interactive discussion group and ask the expert (questions will be answered within 48 hours and usually sooner).

Eligibility criteria:
inclusion criteria: * one parent of a 3-6 year old child with a bmi greater than or equal to the 85th percentile * internet access * english speaking exclusion criteria: * children with a developmental disorder * children with a chronic underlying disease that may contribute to obesity * children taking medication that may interfere with a healthy weight

Keywords: comprehensive health enhancement support system (chess)
effects of jeju red horsehead fish-based, high protein diet on satiety and incretin hormones in diabetes patients

Conditions: Diabetes Mellitus; Obesity

Summary: the aim of our study is to investigate the effects of high-protein diet on satiety and incretin hormones in patients with diabetes.


Eligibility criteria:
inclusion criteria: * diabetes mellitus * subjects signed a written informed consent form exclusion criteria: * liver cirrhosis * chronic renal disease (serum creatinine \> 2mg/dl) * severe congestive heart failure * significant infectious or inflammatory diseases * intractable malignant neoplasm * pregnancy

Keywords: diet incretins gastrointestinal hormones fish proteins
validity of her2-amplified circulating tumor cells to select metastatic breast cancer considered her2-negative for trastuzumab-emtansine (t-dm1) treatment.

Conditions: Metastatic Breast Cancer, HER2 Negative Primary Tumor

Summary: patients with metastatic breast cancer considered her2 negative are screened for her2-amplified circulating tumor cells. if at least her2-amplified circulating tumor cell is detected, patients are treated by trastuzumab - emtansine (t-dm1) in a single arm phase ii with an adaptive design.


Eligibility criteria:
inclusion criteria: inclusion criteria for screening: * breast adenocarcinoma considered her2-negative on the primary tumour or unknown status her2 * a least one metastatic site and/or inoperable loco-regional relapse * measurable disease (recist v1.1) * age from 18 to 75 years * performance status of 0-2 * efficient contraceptive in non-menopause women inclusion criteria for treatment : * at least 1 (cohort " l ") or 3 (cohort " h ") her2 amplified ctc * performance status of 0-2 * adequate cardiac function * adequate hematological and biochemical blood tests exclusion criteria: * life expectancy of less than 3 months * previous history of any other stage iii or iv invasive cancer * male breast cancer * uncontrolled brain metastases * significant cumulated exposure to anthracyclines * current or previous significant history of cardio-vascular/pulmonary disease * previous use of trastuzumab

Keywords: metastatic breast cancer her2 negative primary tumor ctc her2 positive
intracoronary administration of glucocorticoids as a treatment method for no-glucocorticoid treatment for no-reflow in stemi

Conditions: Ischemia-reperfusion Injury; No-reflow

Summary: the goal of this clinical trial is to improve reperfusion therapy in stemi patients with no-reflow phenomenon. based on literature review and pathological studies, the investigators believe that myocardial ischemia-reperfusion injury is primarily due to myocardial edema, which is angiographically manifested by the no-reflow. to restore blood flow, high-dose intracoronary methylprednisolone was applied. the main idea is to stabilize cell membranes and stop the progression of edema. it is local, not systemic, single administration that avoids serious side effects. the primary hypothesis is that hormone administration will improve blood flow to timi 2/3 in timi 0/1after stenting infarct-related artery.

the study involves comparing the main group receiving intracoronary methylprednisolone with a group of patients without intracoronary pharmacotherapy. preliminary results: the use of methylprednisolone allows for the restoration of coronary blood flow but does not affect mortality.

Eligibility criteria:
inclusion criteria: * timi 0/1 flow after successful artery obstruction stenting * men and women aged 40 years and older exclusion criteria: * coronary artery dissection * abrupt intraoperative coronary artery closure * intraoperative thrombosis

Keywords: acute coronary syndrome stemi no-reflow intracoronary glucocorticoids
a study of transcutaneous electrical nerve stimulation for overactive bladder

Conditions: Urge Incontinence; Overactive Bladder

Summary: the purpose of the study is to compare patient centered- outcomes between transcutaneous electrical nerve stimulation (tens) at three locations to treat urinary urge incontinence. one of these locations will be along the tibial nerve, which is traditionally accessed near the medial malleolus. the second site will be on the sacral nerve which is accessed over the sacrum. the third site will be a sham site on the shoulder. this study will evaluate the feasibility of transcutaneous electrical stimulation in the treatment of overactive bladder.


Eligibility criteria:
inclusion criteria: * patients who are clinically diagnosed with urge incontinence, defined as urinary leakage associated with a sudden, strong desire to pass urine that is difficult to defer. * patients with urge predominant mixed incontinence. * patients will need to have answered at "yes" to "leakage related to feeling urgency" on the udi 6 questionnaire. * female * over 18 years of age. * english speaking who are able to give informed consent to participate in the study. * patients who have four urinary incontinence episodes. exclusion criteria: * stress incontinence desiring surgical management. * previous treatment of refractory urge incontinence such as ptns, sns, or intradetrusor onabotulinumtoxin a injections. * neurological conditions affecting continence such as multiple sclerosis, a history of spinal shock within the past year, or neurologic impairment requiring a wheelchair. * urethral diverticulum. * daily catheterization due to urinary retention. * the use of anticholinergic medications for less than 6 weeks. * patients who have pacemakers in place. * patients with limited mobility requiring a wheelchair. * elevated pvr \> 200 cc * untreated urinary tract infection, defined as symptoms and a urine culture with greater than 100,000 cfu/ ml within the last 1 month prior to treatment. * uncorrected stage 3 prolapse.

Keywords: transcutaneous electrical nerve stimulation
clinical trial to investigate the safety, tolerability and pharmacokinetics and pharmacodynamics of jp-1366 oral administration in healthy male subjects

Conditions: Anti-Ulcer Agents

Summary: clinical trial to investigate the safety, tolerability and pharmacokinetics and pharmacodynamics of jp-1366 oral administration in healthy male subjects


Eligibility criteria:
inclusion criteria: * healthy adult males aged between 19 and 50 at screening * weight is between 55 and 90 kg and bmi is between 18.0 and 27.0 * those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc exclusion criteria: * subject has clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history * subject has gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy) * subject has been helicobacter pylori positive * ast (sgot) and alt (sgpt) \> 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization * subject has anatomical disability in insertion and maintenance of ph meter catheter
a trial comparing the glycaemic control of levemir® administered once daily according to two insulin detemir titration algorithms after 20 weeks in subjects with type 2 diabetes mellitus inadequately controlled on metformin treatment with or without other anti-diabetic drugs (oads)

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of the trial is to compare the glycaemic control of levemir® (insulin detemir) administered once daily according to two titration algorithms after 20 weeks in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without other anti-diabetic drugs (oads).


Eligibility criteria:
inclusion criteria: * - diagnosed with type 2 diabetes mellitus at least 3 months prior to visit 1 (week -2) * - treatment with at least 1000 mg metformin per day with/without other oads at a stable dose (at either the maximal tolerated dose or at least half of the maximum recommended dose according to the package insert) for at least 3 months prior to visit 1 * - insulin-naïve subjects * - hba1c above or equal to 7.5% by central laboratory analysis * - body mass index (bmi) below or equal to 35.0 kg/m\^2 exclusion criteria: * - female who is breast-feeding * - the receipt of any investigational product within 4 weeks prior to visit 1 * - any contraindication to insulin detemir according to the domestic labelling * - anticipated change of dose of any systemic treatment with products, which in the investigator's opinion could interfere with glucose metabolism (such as systemic corticosteroids, beta-blockers, monoamine oxidase \[mao\] inhibitors) * - clinically significant diseases which, in the investigator's opinion, may confound the results of the trial or pose additional risk in administering trial product * - any conditions that the investigator judges would interfere with trial participation or evaluation of the results
prevalence of esbl and cpe in french nursing homes

Conditions: Enterobacteriaceae Infections

Summary: carbehpad is a multicentric randomized prevalence study aiming to assess the frequency of enterobacteriaceae (eslb) and carbapenemase producing enterobacteriaceae (cpe) carriage in pays de la loire nursing homes. a sample of 50 nursing homes (nh) in pays de la loire will be randomly selected for inclusion, and a sample of 1/3 of residents of these nh will be screened for esbl and/or cpe fecal carriage. epidemiological data on each resident will be collected to identify risk factors for such carriage.

the pays de la loire region is impacted by 2 main cpe outbreaks in the 2 major university hospitals in this region. a sample of 50 nursing homes (nh) in pays de la loire region (france) will be randomly selected for inclusion in carbehpad study. nh directors will be contacted for agreement for inclusion in carbehpad study. in each of the included nh, a sample of one third of residents will be randomly selected for inclusion. upon agreement, each resident included will be screened through endorectal swabbing for esbl and/or cpe carriage. epidemiological data will be collected for each resident regarding demographic data, risk factors for esbl and/or cpe carriage, comorbidities. these data collected in the nh will be completed with data collection from national nh database regarding: previous hospitalization, treatments (including antibiotics), surgery. data on infection control and prevention will be collected in each nh to assess cross transmission of resistant bacteria in these settings. comparison of isolated strains will be performed to assess clonal dissemination of these resistant enterobacteriaceae in nh. data regarding infection control and prevention in each included nh will be collected aswell. an esbl/cpe carrier status has no impact on medical care in nh regarding french recommendations on management of such resistant microorganisms.

Eligibility criteria:
inclusion criteria: * resident present in the nursing home on the day of the survey. * resident having agreed to be included in the study. * resident with a social security number. exclusion criteria: - resident non-compliant with sampling protocol.

Keywords: carbapenemase enterobacteriaceae extended spectrum beta-lactamases nursing homes prevalence
multiple breath washout as a method for diagnosing lung diseases

Conditions: Pulmonary Fibrosis; COPD; Asthma

Summary: comparison of the new multiple-breath washout method (ndd medizintechnik zürich, trueflow™/truecheck™) with established methods of lung function diagnostics in patients with idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease, asthma and cardiopulmonary healthy individuals.

this diagnostic, prospective, clinical study aims to investigate whether the lung function data measured with the easyonepro®lab device correlates with the lung function data from established measurement methods used in routine clinical practice. it is to be investigated whether the easyonepro®lab measurement leads to equivalent results even with a shorter measurement duration due to an improved evaluation. this is relevant for a broader clinical application in the future. it will also be tested whether the fact that the easyonepro®lab measurement can be carried out largely independently of the employee also leads to better reproducibility of the results. to this end, the intra-individual deviations in repeated measurements will be compared between the methods.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * existing consent * confirmed diagnosis of one of the following diseases * idiopathic pulmonary fibrosis (ipf), confirmed according to the guidelines * chronic obstructive pulmonary disease (copd) with/without emphysema * bronchial asthma * or patients who are admitted with suspected cardiopulmonary dysfunction (e.g. with unclear dyspnoea) and in whom there is no evidence of cardiopulmonary dysfunction during the diagnostic process (comparison group of "healthy" patients). * indication for routine performance of the following pulmonary function tests during the current inpatient stay: whole body plethysmography \& diffusion capacity of the lung (single-breath) exclusion criteria: * age \< 18 years * simultaneous presence of at least two of the following diseases (ipf, copd/emphysema, asthma, pulmonary arterial hypertension) * any medical, psychological or other condition that restricts the patient's ability to give informed consent for voluntary participation in this trial
effect of lidocaine block on gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease

Summary: the goal of this clinical trial is to explore clinical effect of stellate ganglion block on gastroesophageal reflux disease. the main question it aims to answer is: • can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given stellate ganglion block once a day additionally. the study lasts 10 days for each participant. researchers will compare the gastroesophageal reflux disease questionnaire, pressure pain threshold, self-evaluation questionnaire for gastroesophageal reflux disease, to see if the stellate ganglion block can help improve the symptom.

gastroesophageal reflux is a common digestive disorder characterized by the backflow of stomach contents and fluids into the esophagus. the goal of this clinical trial is to explore clinical effect of stellate ganglion block on gastroesophageal reflux disease. the main question it aims to answer is: • can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given stellate ganglion block once a day additionally. the study lasts 10 days for each participant. researchers will compare the gastroesophageal reflux disease questionnaire, pressure pain threshold, self-evaluation questionnaire for gastroesophageal reflux disease, to see if the stellate ganglion block can help improve the symptom.

Eligibility criteria:
inclusion criteria: * gastroesophageal reflux disease diagnosis * aged between 18 and 80 years old. * subjects who tolerate cervical movements in sitting position. * stable vital signs. * normal consciousness exclusion criteria: * contraindications for stellate ganglion block. * peptic ulcer. * previous or present gastric cancer. * previous gastric surgery. * recent fractures or cervical trauma.
open-label study to evaluate the efficacy and safety of fespixon cream for the treatment of pressure injury in sacrum and greater trochanter wound

Conditions: Pressure Injury Stage 2

Summary: open-label study to evaluate the efficacy and safety of fespixon cream for the treatment of pressure injury in sacrum and greater trochanter wound

this study is designed as a single-arm, open-label, multi-center study to evaluate the efficacy and safety of fespixon cream for the treatment of pressure injury in sacrum wound. the duration of this study is: run in/ screen phase (2 weeks); treatment phase (16 weeks); follow-up phase (4 weeks), and visits are conducted every 2 weeks for a total of 12 visits. during the treatment phase, the fespixon cream will be applied to the target ulcer once a day for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. after that, all subjects regardless of wound healing at the end of the treatment phase will be followed for 4 weeks. during the follow-up phase, standard of care will be used for subjects who have unhealed or with recurrent wounds. at each visit, the size and changes of the target pressure ulcer are recorded by photographing. the target pressure ulcer area in the photo is calculated using image pro® plus software.

Eligibility criteria:
1. main inclusion criteria: 1. at least 20 years old, less than 99 (inclusive) years old, with pressure wounds located in the sacral vertebrae and greater trochanter 2. npuap is classified as stage 2 3. no active infection, i.e., idsa level 1 4. ulcer area should be ≥4 cm² and ≤25 cm² ( after necessary debridement and at time of enrollment) 5. if an artificial ostomy is not performed, the distance between the target ulcer and the anus must be greater than 5 cm to prevent contamination 2. main exclusion criteria: 1. those who have an allergic reaction to the ingredients of this product, including those who have been allergic to sulfa drugs, plectranthus amboinicus, centella asiatica or excipients 2. acute infection caused by wound ( wbc \> 12×10³/ul； or c-reactive protein (crp) \> 30 mg/dl) 3. liver and kidney dysfunction ( defined as \[ast or alt\] \> 3× the upper limit of normal; serum creatinine \> 3× the upper limit of normal) 4. pregnant or lactating women 5. infected with human immunodeficiency virus 6. body mass index (bmi) less than 18.5 kg/m² 7. unable to cooperate with changing of subject's position 8. patients with anemia (hgb \< 7.0 g/dl). 9. unable to prevent contaminations such as feces or urinary incontinence 10. malnutrition (albumin\< 2.5 g/dl) 11. presence of tunneling, sinus tracts, dead spaces, etc. at the target pressure ulcer 12. in the opinion of the investigator, entering this trial may pose a threat to subject compliance.

Keywords: fespixon pressure injury wound npiap stage 2